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American Contract Systems, Inc. recalls Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Recalled October 2, 2024 · FDA recall Z-3233-2024 · American Contract Systems
Hazard
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met. · FDA Class II
Units
18 units
Sold at
US Nationwide distribution in the states of MO, MN, MA, OH, NE.
Description
ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.
Product
Bilateral Tubal Ligation Pack, FHBT3T; Medical convenience kit
Manufacturer(s)
American Contract Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →